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Claravis Isotretinoin 10 mg Capsule, Liquid Filled

by Teva Pharmaceuticals USA, Inc. · 3 BLISTER PACK in 1 CARTON (0555-1054-86) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1054-60)

NDC 00555-1054-86

🏷️ FDA NDC (as labeled) 0555-1054-86 billing pads the labeler segment with a zero

This package

Contains10 capsule, liquid filled in 1 blister pack Cost per ea$1.88 NADAC Per package$56.30 / 30 capsules Pack sizes2 compare ↓

Also priced by: Medicaid pays $2.34/unit · Part D plans $3.39/unit — full pricing hub ↓

Also comes in: 10 capsules 00555-1054-56

Rx only Generic On market Non-controlled 🛡 REMS

🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🚨

Active recall for this product.

Class II · Apr 6, 2026 — Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin (Teva Pharmaceuticals USA, Inc) · FDA recall D-0521-2026

Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

⚠️

Other active recalls for Isotretinoin (different manufacturers) — 4 · tap to view

These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.

Class II · Feb 24, 2026 — Failed Dissolution Specifications (MYLAN PHARMACEUTICALS INC) · FDA recall D-0399-2026

Class II · Jan 12, 2026 — Superpotent and Subpotent (Teva Pharmaceuticals USA, Inc) · FDA recall D-0446-2026

Class II · Jan 12, 2026 — Superpotent and Subpotent (Teva Pharmaceuticals USA, Inc) · FDA recall D-0445-2026

Class II · Mar 28, 2024 — Superpotent Drug: The 3-month stability result for assay was found to be above specification limit (Teva Pharmaceuticals USA, Inc) · FDA recall D-0439-2024

Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 0555-1054-86

Product NDC 0555-1054

11-digit billing NDC 00555105486

NCPDP billing unit EA — each (per item)

RxCUI 197843, 197844, 197845, 403930, 404059, 404062, 404065, 643488

UNII EH28UP18IF

Application # ANDA076356

SPL Set ID a31fd109-d0fd-4ab9-ba98-a3d64333c18d

Established class (EPC) Retinoid

Chemical class Retinoids

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2003-05-09

Route ORAL

Dosage form CAPSULE, LIQUID FILLED

Substance ISOTRETINOIN

GCN Seq No 036045

GCN 59841

HICL code 002476

Ingredient (HICL) Isotretinoin

HIC1 code L

Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue

HIC2 code L1

Therapeutic class — intermediate (HIC2) Drugs To Treat Specific Top Diseases (Systemic)

HIC3 code L1B

Therapeutic class — specific (HIC3) Acne Agents,Systemic

AHFS code 84:28.00.00

AHFS class Keratolytic Agents

FDB label name CLARAVIS 10 MG CAPSULE

FDB brand name Claravis

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB1 · RLD · RS

Why two NDCs? The FDA registers this code as 0555-1054-86 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00555-1054-86. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Retinoid class.

Pharmacologic class Retinoid

Drug family (ATC) Retinoids for topical use in acne, Retinoids for treatment of acne

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerTeva Pharmaceuticals USA, Inc.

Application holderTEVA PHARMACEUTICALS USA

FDA applicationANDA076356 (ANDA)

Labeler code00555

First marketedMay 2003

Product typeHuman Prescription Drug

Portfolio504 products on file

🔎 All NDCs from Teva Pharmaceuticals USA, Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name CLARAVIS 10 MG CAPSULE Ingredient Isotretinoin

📖 What it is MedlinePlus · NLM

Isotretinoin is used to treat severe recalcitrant nodular acne (a certain type of severe acne) that has not been helped by other treatments, such as antibiotics. Isotretinoin is in a class of medications called retinoids. It works by slowing the production of certain natural substances that can cause acne.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Isotretinoin is one of the most tightly controlled medications in the U.S. because it causes extremely severe birth defects — even a single short exposure during pregnancy can be d...
Why do I have to go through so many steps just to get this prescription?
For most isotretinoin products — including Accutane, Amnesteem, Claravis, and generic isotretinoin capsules — yes, food is essential. Eating with your dose more than doubles how mu...
Do I really need to take this with food every time?

📖 Read our full Isotretinoin guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Isotretinoin — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Isotretinoin (49 interactions) — ranked by severity →

Nutrient depletion considerations

Isotretinoin may be associated with lower levels of 4 nutrients — worth a chat with your pharmacist, not a cause for alarm.

ACETYL-L-CARNITINE Insignificant Depletion L-CARNITINE Insignificant Depletion PROPIONYL-L-CARNITINE Insignificant Depletion FOLIC ACID Moderate Depletion

🧪 Full Isotretinoin nutrient depletion report →

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color gray / brown / orange

ShapeCapsule

Imprintbarr;936

Size19 mm

ScoringNot scored

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII H4N855PNZ1
Alpha-tocopherol is a form of vitamin E, a fat-soluble antioxidant derived from natural or synthetic sources. In medicines, it prevents oils and fats from breaking down and becoming rancid, protecting the product's stability and shelf life.
UNII REK4960K2U
Butylated hydroxyanisole is a synthetic preservative that prevents oils and fats in medicines from spoiling or becoming rancid. It keeps the medicine stable and extends its shelf life.
UNII ECW0LZ41X8
A synthetic red dye used to color tablets and capsules. It helps make medicines visually distinctive so patients can easily identify their medication.
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
UNII A2M91M918C
A plant-based oil derived from soybeans that has been chemically hardened to make it solid or semi-solid at room temperature. It acts as a binder, filler, and lubricant to help hold the tablet together and allow it to move smoothly during manufacturing and packaging.
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
UNII 241ATL177A
Soybean oil is a natural plant oil derived from soybean seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients and improve how the body absorbs them.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
UNII 7G1J5DA97F
White wax is a refined, bleached plant-based or mineral wax that serves as a coating and hardening agent in medicines. It helps control how fast the drug dissolves and improves the product's texture and appearance.

14 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per ea	Per package
Retail pharmacies payNADAC · weekly	$1.877	$56.30 / 30 capsules
Medicaid paysCMS SDUD · 12 mo	$2.34	$70.09 / 30 capsules
Medicare drug plans payPart D · Q2 2026	$3.39	$101.55 / 30 capsules

NADAC price history (per ea) — tap or hover for the price & month

▼ Down 33% over the last 21 months.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Amnesteem 10 mg 00378-6611-93	Mylan	30 capsules	$1.877	AB1	Availability likely	—
Claravis 10 mgthis 00555-1054-86	Teva	10 capsules	$1.877	AB1	Availability likely	—
Isotretinoin 10 mg 00832-8301-30	Upsher-Smith	10 capsules	$1.877	AB1	Availability likely	—
Zenatane 10 mg 55111-0135-81	Dr.	10 capsules	$1.877	AB1	Availability likely	—
Zenatane 10 mg 68001-0652-17	BluePoint	10 capsules	$1.877	AB1	Availability likely	—
Isotretinoin 10 mg 68308-0781-30	Mayne	10 capsules	$1.877	AB1	Availability likely	—
Isotretinoin 10 mg 69238-1174-03	Amneal	10 capsules	$1.877	AB1	Availability likely	—
Isotretinoin 10 mg 00245-0570-01	Upsher-Smith	10 capsules	$11.936	AB2	Availability likely	+536%
Isotretinoin 10 mg 00591-2433-15	Actavis	30 capsules	$11.936	AB2	Availability likely	+536%
Isotretinoin 10 mg 57664-0020-97	Sun	30 capsules	$11.936	AB2	Availability likely	+536%
Isotretinoin 10 mg 59651-0631-03	Aurobindo	30 capsules	$11.936	AB2	Availability likely	+536%
Isotretinoin 10 mg 68308-0570-30	Mayne	10 capsules	$11.936	AB2	Availability likely	+536%
Isotretinoin 10 mg 70710-1574-08	Zydus	30 capsules	$11.936	AB2	Availability likely	+536%
Absorica 10 mg 10631-0115-31	Sun	30 capsules	—	AB2	FDA listed	—
Isotretinoin 10 mg 69238-1254-03	Amneal	30 capsules	—	—	FDA listed	—
Isotretinoin 10 mg 70710-1022-04	Zydus	100 capsules	—	AB1	FDA listed	—
Isotretinoin 10 mg 70771-1557-04	Zydus	100 capsules	—	AB1	FDA listed	—
Isotretinoin 10 mg 70771-1662-08	Zydus	30 capsules	—	AB2	FDA listed	—
Accutane 10 mg 72143-0251-30	JG	10 capsules	—	AB1	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2003

On the market since

May 2003

📍

2026

Currently FDA-listed

23 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00555-1054-86, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

642

Units reimbursed last 4 qtrs

24.6K

Gross reimbursed last 4 qtrs

$57.4K

Avg / prescription

$89.37

Avg / unit

$2.3362

Latest quarter Q4 2025

164Rx

Medicaid pays / ea

$2.3362

gross reimbursed

NADAC / ea

$1.8768

acquisition cost

Spread

+$0.4594

+24% vs cost

What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

71% FFS 29% MCO

Fee-for-service · 454 Rx Managed care · 188 Rx

State Medicaid map

Units reimbursed · per 100k residents

4.6105

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Hawaii 105 /100k

2 New York 34.4 /100k

3 Pennsylvania 25.1 /100k

4 California 24.5 /100k

5 New Jersey 10.7 /100k

6 Maryland 9.7 /100k

7 Colorado 8.7 /100k

8 Texas 4.6 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

10 capsules this page00555-1054-86 642 Rx · $57,376

10 capsules00555-1054-56 76 Rx · $6,051

Drug total (last 4 qtrs): 718 Rx · 27,430 units · $63,427 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Claravis — the program that covers self-administered drugs. 1 manufacturer.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Claravis. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$136.1K

Claims incl. refills

826

Beneficiaries

570

Spend / beneficiary

$238.86

Spend / claim

$164.83

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🛡

This drug has a REMS — iPLEDGE REMS. A Risk Evaluation & Mitigation Strategy is an FDA-required safety program. It is available only through a restricted program (certified prescribers/pharmacies, enrollment, or required monitoring). See the boxed warning & full label below, and REMS@FDA ↗.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Claravis (this brand).

Top reported reactions

Unintended Pregnancy1,885

Depression1,742

Pregnancy1,114

Suicidal Ideation986

Abortion Induced829

Headache802

Mood Altered778

Age at onset

Neonate63

Infant22

Child89

Adolescent623

Adult1,513

Elderly25

Reporter sex

Male · 31%

Female · 68%

Unknown · 1%

Serious outcomes

Hospitalization1,763

Death512

Disabling436

Life-threatening335

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
00555-1054-56	10 BLISTER PACK in 1 CARTON (0555-1054-56) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1054-60)	$1.88 / ea	$187.68	2003-05-09	Active
00555-1054-86 You're viewing this	3 BLISTER PACK in 1 CARTON (0555-1054-86) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1054-60)	$1.88 / ea	$56.30	2003-05-09	Active

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($1.88 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 89% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00555-1054-86?

NDC 00555-1054-86 is listed by the FDA — 3 blister pack in 1 carton / 10 capsule, liquid filled in 1 blister pack.

What NDC number is used to bill for this package of Claravis Isotretinoin 10 mg Capsule, Liquid Filled?

Bill NDC 00555-1054-86 — the 11-digit billing format is 00555105486. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide

🚨 Boxed Warning ~1 min read ▾

WARNING: EMBRYO-FETAL TOXICITY - CONTRAINDICATED IN PREGNANCY Claravis can cause life-threatening birth defects and is contraindicated in pregnancy . There is an extremely high risk that life-threatening birth defects will result if pregnancy occurs while taking any amount of Claravis even for short periods of time. Potentially any fetus exposed during pregnancy can be affected.

There are no accurate means of determining prenatally whether an exposed fetus has been affected . If pregnancy occurs, discontinue Claravis immediately and refer the patient to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), and Use in Specific Populations ( 8.1 )] . Because of the risk of embryo-fetal toxicity, Claravis is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the iPLEDGE REMS [see Warnings and Precautions ( 5.2 )].

WARNING: EMBRYO-FETAL TOXICITY - CONTRAINDICATED IN PREGNANCY See full prescribing information for complete boxed warning. Claravis can cause life-threatening birth defects and is contraindicated in pregnancy. There is an extremely high risk that life-threatening birth defects will result if pregnancy occurs while taking Claravis in any amount, even for short periods of time.

Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected. ( 4 , 5.1 , 8.1 ) Claravis is available only through a restricted program called the iPLEDGE REMS.

( 5.2 )

🎯 Indications and Usage 219 words ▾

1 INDICATIONS AND USAGE Claravis ™ (isotretinoin capsules USP) is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, Claravis is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use : If a second course of Claravis treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of treatment [see Dosage and Administration ( 2.2 )].

Claravis (isotretinoin capsules) is a retinoid indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, Claravis is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. ( 1 ) Limitations of Use : If a second course of Claravis treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of treatment.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Evaluations Prior to Prescribing and Use of Claravis: In patients who can get pregnant, only prescribe Claravis after verification and documentation that they are not pregnant. See the Full Prescribing Information for the detailed requirements prior to prescribing Claravis ( 2.1 , 8.3 ) Complete the following laboratory tests in all patients: fasting lipid profile and liver function tests. ( 2.1 ) Recommended dosage is 0.5 to 1 mg/kg/day given in two divided doses with food for 15 to 20 weeks ( 2.2 ) Adult patients with very severe disease (scarring, trunk involvement) may increase dosage to 2 mg/kg/day in two divided doses with food.

( 2.1 ) Once daily dosing is not recommended. ( 2.2 ) If a dose is missed, just skip that dose. Do not take two doses at the same time.

( 2.2 ) See the Full Prescribing Information for the recommended duration of use ( 2.3 )

2.1Evaluations Prior to Prescribing and Use of Claravis In patients who can get pregnant, only prescribe Claravis after verification and documentation that they are not pregnant [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 , 5.2 )]. For the detailed requirements prior to prescribing Claravis, see Use in Specific Populations ( 8.3 )]. Prior to Claravis use in all patients, complete the following laboratory testing: A fasting lipid profile including triglycerides [see Warnings and Precautions ( 5.7 , 5.14 )] .

Liver function tests [see Warnings and Precautions ( 5.9 , 5.14 )] .

2.2Recommended Dosage The recommended dosage range for Claravis is 0.5 to 1 mg/kg/day given in two divided doses with food for 15 to 20 weeks (see Tables 1 and 2, respectively) [see Clinical Pharmacology ( 12.3 )] . Table 1: Claravis: Recommended Divided Doses (0.5 mg/kg/day dosage) Body Weight First Dose Second Dose 40 kg 10 mg 10 mg 50 kg 12.5 mg 12.5 mg 60 kg 15 mg 15 mg 70 kg 17.5 mg 17.5 mg 80 kg 20 mg 20 mg 90 kg 22.5 mg 22.5 mg 100 kg 25 mg 25 mg Table 2: Claravis: Recommended Divided Doses (1 mg/kg/day dosage) Body Weight First Dose Second Dose 40 kg 20 mg 20 mg 50 kg 25 mg 25 mg 60 kg 30 mg 30 mg 70 kg 35 mg 35 mg 80 kg 40 mg 40 mg 90 kg 45 mg 45 mg 100 kg 50 mg 50 mg To decrease the risk of esophageal irritation, instruct patients to swallow the capsules with a full glass of liquid.

Swallow capsules whole. Do not split, crush, chew, or suck on the capsules. During treatment, the dosage may be adjusted according to response of the disease and/or adverse reactions, some of which may be dose-related.

Adult patients whose disease is very severe with scarring or is primarily manifested on the trunk may require dosage adjustments up to 2 mg/kg/day for Claravis in divided doses with food, as tolerated (see Table 3). Table 3: Claravis: Recommended Divided Doses (2 mg/kg/day dosage) Body Weight First Dose Second Dose 40 kg 40 mg 40 mg 50 kg 50 mg 50 mg 60 kg 60 mg 60 mg 70 kg 70 mg 70 mg 80 kg 80 mg 80 mg 90 kg 90 mg 90 mg 100 kg 100 mg 100 mg The safety and effectiveness of once daily dosing with Claravis has not been established and is not recommended.

If a dose of Claravis is missed, just skip that dose. Do not take two doses of Claravis at the same time.

2.3Recommended Duration of Use A course of treatment is 15 to 20 weeks. If the total nodule count has been reduced by more than 70% prior to completing 15 to 20 weeks of treatment, may discontinue Claravis. After a period of 2 months or more off treatment, and if warranted by persistent or recurring severe nodular acne, may initiate a second course of Claravis in patients who have completed skeletal growth.

The use of another course of Claravis treatment is not recommended before a two-month waiting period because the patient's acne may continue to improve after a 15 to 20-week course of treatment. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth. Long-term use of Claravis, even in low dosages, has not been studied, and is not recommende…

💊 Dosage Forms and Strengths 154 words ▾

3 DOSAGE FORMS AND STRENGTHS Capsules: 10 mg: Two-piece hard gelatin capsule with light gray opaque cap and light gray opaque body filled with yellow oily dispersion. Imprinted in red ink barr on one piece and 934 on the other piece. 20 mg: Two-piece hard gelatin capsule with brown opaque cap and brown opaque body filled with yellow oily dispersion.

Imprinted in white ink barr on one piece and 935 on the other piece. 30 mg: Two-piece hard gelatin capsule with orange opaque cap and orange opaque body filled with yellow oily dispersion. Imprinted in black ink barr on one piece and 454 on the other piece.

⛔ Contraindications 86 words ▾

4 CONTRAINDICATIONS Claravis is contraindicated in: Pregnancy [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )] . Patients with hypersensitivity to isotretinoin (or Vitamin A, given the chemical similarity to isotretinoin) or to any of its components (anaphylaxis and other allergic reactions have occurred) [see Warnings and Precautions ( 5.14 )] . Claravis is contraindicated in: Pregnancy ( 4 , 8.1 ) Patients with hypersensitivity to isotretinoin (or Vitamin A) or any of its components ( 4.2 , 5.13 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Psychiatric Disorders (depression, psychosis, suicidal thoughts and behavior, and aggressive and/or violent behaviors): Prior to and during treatment assess for these conditions; stop if these conditions occur on treatment ( 5.3 ) Intracranial Hypertension (Pseudotumor Cerebri) : Avoid concomitant use with tetracyclines ( 5.4 , 7.2 ) Serious Skin Reactions : Monitor for Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious skin reactions and discontinue treatment if they occur ( 5.5 ) Acute Pancreatitis : If pancreatitis symptoms occur, discontinue treatment ( 5.6 ) Lipid Abnormalities (hypertriglyceridemia, low HDL, and elevation of cholesterol): Monitor lipid levels at regular intervals; stop if hypertriglyceridemia cannot be controlled ( 5.7 ) Hearing Impairment : Discontinue and refer to specialized care ( 5.8 ) Hepatotoxicity : Monitor liver function tests prior to and during treatment ( 5.9 , 5.14 ) Inflammatory Bowel Disease : Discontinue for abdominal pain, rectal bleeding, or severe diarrhea ( 5.10 ) Musculoskeletal Abnormalities : Arthralgias, back pain, decreases in bone mineral density and premature epiphyseal closure ( 5.11 ) Ocular Abnormalities e.g., corneal opacities, decreased night vision: If visual symptoms occur, discontinue, and refer for an ophthalmological exam ( 5.12 )

5.1Embryo-Fetal Toxicity Claravis is contraindicated in pregnancy [see Contraindications ( 4 )] . Based on human data, Claravis can cause fetal harm when administered to a pregnant patient. There is an extremely high risk that life-threatening birth defects will result if pregnancy occurs while taking any amount of Claravis even for short periods of time.

Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining prenatally whether an exposed fetus has been affected. Major congenital malformations, spontaneous abortions, and premature births have been documented following exposure to isotretinoin during pregnancy [see Use in Specific Populations ( 8.1 )].

If a pregnancy occurs during Claravis treatment, immediately discontinue Claravis and refer the patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling. Immediately report any suspected fetal exposure during or 1 month after Claravis treatment to the FDA via the MedWatch telephone number 1-800-FDA-1088, and also to the iPLEDGE pregnancy registry at 1-866-495-0654 or via the internet (www.ipledgeprogram.com). Inform patients not to donate blood during Claravis treatment and for 1 month following discontinuation because the blood might be given to a pregnant patient whose fetus must not be exposed to isotretinoin.

Claravis is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) [see Warnings and Precautions ( 5.2 )]. 5.2 iPLEDGE REMS Because of the risk of embryo-fetal toxicity, Claravis is available only through a restricted program under a REMS called the iPLEDGE REMS [see Warnings and Precautions ( 5.1 )] . Notable requirements of the iPLEDGE REMS include the following: Prescribers must be certified with the REMS and comply with the REMS requirements, including the following: Assess the reproductive status of all patients prior to initiating and during treatment Counsel patients who cannot get pregnant on the risk and REMS requirements prior to initiating treatment.

Counsel patients who can get pregnant on: The risk and REMS requirements prior to and during treatment. Pregnancy prevention requirements prior to and during treatment, or refer patients who can get pregnant to an expert for such counseling Comply with the pregnancy testing requirements. Assess the pregnancy status for patients who can get pregnant by reviewing pregnancy tests and documenting a negative result prior to each prescription.

Report all pregnancies to the REMS. Patients who can become pregnant must be enro…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following adverse reactions with Claravis are described in more detail in other sections of the labeling: Embryo-Fetal Toxicity [see Warnings and Precautions ( 5.1 )] Psychiatric Disorders [see Warnings and Precautions ( 5.3 )] Intracranial Hypertension (Pseudotumor Cerebri) [see Warnings and Precautions ( 5.4 )] Serious Skin Reactions [see Warnings and Precautions ( 5.5 )] Pancreatitis [see Warnings and Precautions ( 5.6 )] Lipid Abnormalities [see Warnings and Precautions ( 5.7 )] Hearing Impairment [see Warnings and Precautions ( 5.8 )] Hepatotoxicity [see Warnings and Precautions ( 5.9 )] Inflammatory Bowel Disease [see Warnings and Precautions ( 5.10 )] Musculoskeletal Abnormalities [see Warnings and Precautions ( 5.11 )] Ocular Abnormalities [see Warnings and Precautions ( 5.12 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.13 )] The following adverse reactions, presented alphabetically by body system, associated with the use of Claravis were identified in clinical studies or postmarketing reports.

Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse Reactions with a Dose Relationship Cheilitis and hypertriglyceridemia were dose related. Body as a Whole Allergic reactions, dry mouth, edema, fatigue, irritability, lymphadenopathy, pain, systemic hypersensitivity, vasculitis, weight loss.

Cardiovascular Palpitation, stroke, tachycardia, vascular thrombotic disease Endocrine/Metabolism and Nutritional Alterations in blood sugar levels, decreased appetite, hypertriglyceridemia, weight fluctuation. Gastrointestinal Abdominal pain, bleeding and inflammation of the gums, colitis, constipation, diarrhea, esophageal ulceration, esophagitis, ileitis, nausea, hepatitis, inflammatory bowel disease, other nonspecific gastrointestinal symptoms, pancreatitis, vomiting. Hematologic Anemia, neutropenia including severe neutropenia, rare reports of agranulocytosis. thrombocytopenia, Infections and Infestations Infections (including disseminated herpes simplex, hordeolum, nasopharyngitis, upper respiratory tract infections).

Laboratory Abnormalities The following lab test values were increased: alkaline phosphatase, ALT, AST, bilirubin, cholesterol, CPK, fasting blood glucose, gamma-glutamyltransferase, LDH, LDL, platelet counts, sedimentation rate, triglycerides, and uric acid (hyperuricemia). The following lab test values were decreased: high density lipoprotein (HDL), RBC parameters, and WBC counts. Urine findings included increased microscopic or gross hematuria, proteinuria, white cells.

Musculoskeletal and Connective Tissue Arthritis, calcification of tendons and ligaments; decreases in bone mineral density; elevations of CPK/rare reports of rhabdomyolysis musculoskeletal symptoms (sometimes severe) including arthralgia, back pain, extremity pain, musculoskeletal pain or stiffness, myalgia, neck pain [see Warnings and Precautions ( 5.11 )] ; other types of bone abnormalities; premature epiphyseal closure; skeletal hyperostosis; tendonitis; and transient chest pain. Neurological Dizziness, drowsiness, intracranial hypertension (pseudotumor cerebri), headache, insomnia, lethargy, malaise, nervousness, paresthesia, seizures, syncope, stroke, and weakness.

Psychiatric Aggression, auditory hallucinations, anger, depression, emotional instability, insomnia, irritability, panic attack, psychosis, suicidal ideation, suicide, suicide attempts, violent behaviors. In some patients who reported depression, their depression subsided with discontinuation of Claravis treatment but recurred with reinstitution of Claravis treatment. Reproductive System Abnormal menses, sexual dysfunction that may continue after discontinuation of treatment (including erectile dysfunction, decreased libido, decreased vaginal lubrication, and vaginal dryness).

Respi…

🔄 Drug Interactions 149 words ▾

7 DRUG INTERACTIONS Vitamin A: Avoid concomitant use ( 7.1 ) Tetracyclines: Avoid concomitant use ( 7.2 )

7.1Vitamin A Avoid concomitant use of Claravis with supplements containing vitamin A. Claravis is closely related to vitamin A. Therefore, concomitant use of Claravis with vitamin A may lead to Claravis-related adverse reactions.

7.2Tetracyclines Avoid concomitant use of Claravis with tetracyclines. Claravis use has been associated with a number of cases of intracranial hypertension (pseudotumor cerebri), some of which involved concomitant use with tetracyclines [see Warnings and Precautions ( 5.4 )].

7.3Oral Contraceptives It is not known if there is an interaction between Claravis with oral contraceptives that do not contain norethindrone and ethinyl estradiol. Claravis did not result in clinically significant changes in the pharmacokinetics of norethindrone and ethinyl estradiol when used concomitantly with norethindrone and ethinyl estradiol oral contraceptive [see Clinical Pharmacology ( 12.3 )] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation : Breastfeeding not recommended ( 8.2 ). In Patients Who Can Get Pregnant : Pregnancy testing is required prior to, during, and after Claravis treatment. See the Full Prescribing Information for the detailed pregnancy test and contraception requirements. ( 8.3 ).

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that documents pregnancies in patients exposed to isotretinoin during pregnancy. Report any suspected fetal exposure during or 1 month after Claravis treatment immediately to the FDA via the MedWatch telephone number 1-800-FDA-1088 and also to the iPLEDGE pregnancy registry at 1-866-495-0654 or via the internet (www.ipledgeprogram.com). Risk Summary Claravis is contraindicated during pregnancy because isotretinoin can cause fetal harm when administered to a pregnant patient.

There is an increased risk of major congenital malformations, spontaneous abortions, and premature births following isotretinoin exposure during pregnancy in humans [see Warnings and Precautions ( 5.1 )]. If Claravis is used during pregnancy, or if the patient becomes pregnant while taking Claravis, apprise the patient of the potential hazard to a fetus. If pregnancy occurs during treatment of a patient who is taking Claravis, immediately discontinue Claravis and refer the patient to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.

Data Human Data: Major congenital malformations that have been documented following Claravis exposure include malformations of the face, eyes, ears, skull, central nervous system (CNS), cardiovascular system, and thymus and parathyroid glands. External malformations include: skull; ear (including anotia, micropinna, small or absent external auditory canals); eye (including microphthalmia); facial dysmorphia and cleft palate. Internal abnormalities include: CNS (including cerebral and cerebellar malformations, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular; thymus gland; parathyroid hormone deficiency.

In some cases, death has occurred as a result of the malformations. Cases of IQ scores less than 85 with or without other abnormalities have been reported in children exposed in utero to isotretinoin. An increased risk of spontaneous abortion and premature births have been reported with isotretinoin exposure during pregnancy.

8.2Lactation Risk Summary There are no data on the presence of isotretinoin in either animal or human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions in nursing infants from isotretinoin, advise patients that breastfeeding is not recommended during treatment with Claravis, and for at least 8 days after the last dose of Claravis.

8.3Females and Males of Reproductive Potential All patients who can become pregnant must comply with the iPLEDGE REMS requirements [see Warnings and Precautions ( 5.2 )] . Pregnancy Testing In patients who can get pregnant, pregnancy testing is required prior to, during, and after Claravis treatment. Pregnancy Testing Prior to Prescribing Claravis: In patients who can get pregnant, only prescribe Claravis after verification and documentation that they are not pregnant: Complete the first urine or serum pregnancy test (screening test) in a medical setting (e.g., prescriber’s office, clinic, laboratory) and verify and document that the test is negative, AND For patients with: Regular menstrual cycles, complete the second urine or serum pregnancy test (confirmatory test) in a medical setting (1) at least 30 days after the screening test and during the first five days of their menstrual period immediately preceding the beginning of Claravis treatment, AND (2) after the patient has used their chosen pregnancy prevention methods (i.e., two forms of contraception or committed to abstinence) for at least 30 days.

Verify and document that the confirmatory…

🤰 Pregnancy ~1 min read ▾

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of Claravis for the treatment of severe recalcitrant nodular acne have been established in non-pregnant pediatric patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater who are unresponsive to conventional treatment, including systemic antibiotics. Use of Claravis in this age group for this indication is supported by evidence from a clinical trial comparing 103 pediatric patients (13 to 17 years) to 197 adults (both with severe recalcitrant nodular acne).

Results from this study demonstrated that Claravis, at a dosage of 1 mg/kg/day given in two divided doses, was similarly effective in treating severe recalcitrant nodular acne in both pediatric and adult patients. The safety and effectiveness of Claravis in pediatric patients less than 12 years of age have not been established. Adverse Reactions in Pediatric Patients In trials with Claravis, adverse reactions reported in pediatric patients aged 12 to 17 years old were similar to those described in adults except for the increased incidence of back pain and arthralgia (both of which were sometimes severe) and myalgia in pediatric patients.

In a trial of pediatric patients aged 12 to 17 years old treated with Claravis, approximately 29% (104/358) developed back pain. Back pain was severe in 14% (14/104) of the cases and occurred at a higher frequency in female patients than male patients. Arthralgias occurred in 22% (79/358) of pediatric patients including severe arthralgias in 8% (6/79) of patients.

Evaluate the musculoskeletal system in pediatric patients 12 years of age and older who present with these symptoms during or after a course of Claravis. Consider discontinuing Claravis if any significant abnormality is found. Effects on Bone Mineral Density in Pediatric Patients In an open-label clinical trial (N=217) of a single course of treatment with Claravis for adolescents with severe recalcitrant nodular acne, BMD at several skeletal sites were assessed: One patient had a decrease in lumbar spine BMD >4% based on unadjusted data; 16 (8%) patients had decreases in lumbar spine BMD >4%, and all the other patients (92%) did not have significant decreases or had increases (adjusted for body mass index).

Nine patients (5%) had a decrease in total hip BMD >5% based on unadjusted data. Twenty-one (11%) patients had decreases in total hip BMD >5%, and all the other patients (89%) did not have significant decreases or had increases (adjusted for body mass index). Follow-up trials performed in 8 of the patients with decreased BMD for up to 11 months thereafter demonstrated increasing BMD in 5 patients at the lumbar spine, while the other 3 patients had lumbar spine BMD measurements below baseline values.

Total hip BMD remained below baseline (range -1.6% to -7.6%) in 5 of 8 patients (63%). In a separate open-label extension trial of 10 patients including those ages 13 to 17 years, who started a second course of Claravis 4 months after the first course, two patients showed a decrease in mean lumbar spine BMD up to 3.3%. Epiphyseal Closure There have been spontaneous literature reports of premature epiphyseal closure in acne patients who received the recommended dosage of Claravis.

The effect of multiple courses of Claravis on epiphyseal closure is unknown [see Warnings and Precautions ( 5.11 )] .

🧓 Geriatric Use 42 words ▾

8.5Geriatric Use Clinical studies of Claravis did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. The effects of aging may increase some risks associated with Claravis treatment.

🆘 Overdosage 118 words ▾

10 OVERDOSAGE Isotretinoin overdosage has been associated with vomiting, facial flushing, cheilosis, abdominal pain, headache, dizziness, and ataxia. Evaluate patients who can become pregnant who present with an isotretinoin overdosage for pregnancy. Because an overdosage would be expected to result in higher levels of isotretinoin in semen than found during a normal treatment course, instruct male patients treated with Claravis to use a condom, or avoid reproductive sexual activity with a patient who is or might become pregnant, for 1 month after the overdose.

Instruct all patients with Claravis overdose not donate blood for at least 1 month. If an overdose occurs, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The exact mechanism of action of Claravis in the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater who are unresponsive to conventional therapy, including systemic antibiotics is unknown. Isotretinoin, a retinoid, inhibits sebaceous gland function and keratinization. Clinical improvement in nodular acne patients occurs in association with a reduction in sebum secretion.

The decrease in sebum secretion is temporary and reflects a reduction in sebaceous gland size and an inhibition of sebaceous gland differentiation.

12.2Pharmacodynamics Decreased sebum secretion is related to the dose and duration of treatment with Claravis.

12.3Pharmacokinetics The following parameters are presented as mean [coefficient of variation (CV%)] following a single oral dose of 80 mg of Claravis in healthy adult subjects unless otherwise stated. Isotretinoin C max is 862 (22%) ng/mL and AUC 0-inf is 10,004 (22%) ng*h/mL when Claravis was administered with food in healthy adults. Isotretinoin accumulation ratio ranged from 0.90 to 5.43 in patients with cystic acne after multiple doses.

No clinically significant differences in the pharmacokinetics of isotretinoin were observed between patients with nodular acne and healthy subjects without acne. Absorption Isotretinoin time to maximum concentration (T max ) is 5.3 hours (77%) when administered with food. Effect on Food: Isotretinoin AUC 0-inf increased 2.7-fold and C max increased 2.9-fold relative to the fasted state following a high-fat meal.

In addition, the extent of formation of all metabolites was higher, T max increased to 5.3 hours (77%), and the elimination half-life was unchanged under fed conditions [see Dosage and Administration ( 2.1 )] . Distribution Isotretinoin is more than 99.9% bound to plasma proteins, primarily to albumin. Elimination The mean ± SD elimination half-life of isotretinoin is 21 ± 8.2 hours and 24 ± 5.3 hours for its 4-oxo-isotretinoin metabolite.

Metabolism: Isotretinoin is primarily metabolized by CYP2C8, 2C9, 3A4, and 2B6 in vitro . Isotretinoin and its metabolites are further metabolized into conjugates. Isotretinoin is metabolized into at least three metabolites (4-oxo-isotretinoin, retinoic acid (tretinoin), and 4-oxo-retinoic acid (4-oxo-tretinoin)) which are detected in human plasma.

Retinoic acid and 13-cis-retinoic acid are geometric isomers and show reversible interconversion. The administration of one isomer will give rise to the other. Isotretinoin is also irreversibly oxidized to 4-oxo-isotretinoin, which forms its geometric isomer 4-oxo-tretinoin.

The exposure of adult cystic acne patients to 4-oxo-isotretinoin at steady state under fasted and fed conditions was approximately 3.4 times higher than that of isotretinoin. All of these metabolites possess retinoid activity in vitro , however the clinical significance is unknown. Excretion: Following administration of 80 mg of radiolabeled isotretinoin as a liquid suspension, the metabolites of isotretinoin were excreted in feces and urine in relatively equal amounts (total of 65% to 83%).

Specific Populations Pediatric Patients: No clinically statistically significant differences in isotretinoin pharmacokinetics were observed based on age (12 to 15 years, and ≥18 years) in patients who received single and multiple doses of Claravis. In both age groups, 4- oxo -isotretinoin was the major metabolite compared to tretinoin and 4- oxo -tretinoin . Drug Interaction Studies Clinical Studies: Norethindrone and Ethinyl Estradiol : There were no clinically significant differences in the pharmacokinetics of norethindrone and ethinyl estradiol after the concomitant use of Claravis (dosage of 1 mg/kg/day) with an oral contraceptive agent in premenopausal female patients with severe recalcitrant nodular acne.

Additionally, there was no clinically significan…

🧬 Mechanism of Action 97 words ▾

The decrease in sebum secretion is temporary and reflects a reduction in sebaceous gland size and an inhibition of sebaceous gland differentiation.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Claravis ™ (isotretinoin capsules USP) is available as: 10 mg: Two-piece hard gelatin capsule with light gray opaque cap and light gray opaque body filled with yellow oily dispersion. Imprinted in red ink barr on one piece and 934 on the other piece. Available in cartons of 30 capsules containing 3 prescription blister packs of 10 capsules (NDC 0555-1054-86) and 100 capsules containing 10 prescription blister packs of 10 capsules (NDC 0555-1054-56).

20 mg: Two-piece hard gelatin capsule with brown opaque cap and brown opaque body filled with yellow oily dispersion. Imprinted in white ink barr on one piece and 935 on the other piece. Available in cartons of 30 capsules containing 3 prescription blister packs of 10 capsules (NDC 0555-1055-86) and 100 capsules containing 10 prescription blister packs of 10 capsules (NDC 0555-1055-56).

30 mg: Two-piece hard gelatin capsule with orange opaque cap and orange opaque body filled with yellow oily dispersion. Imprinted in black ink barr on one piece and 454 on the other piece. Available in cartons of 30 capsules containing 3 prescription blister packs of 10 capsules (NDC 0555-1056-86).

40 mg: Two-piece hard gelatin capsule with light orange opaque cap and light orange opaque body filled with yellow oily dispersion. Imprinted in black ink barr on one piece and 936 on the other piece. Available in cartons of 30 capsules containing 3 prescription blister packs of 10 capsules (NDC 0555-1057-86) and 100 capsules containing 10 prescription blister packs of 10 capsules (NDC 0555-1057-56).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Keep this and all medications out of the reach of children.

📋 Description ~1 min read ▾

11 DESCRIPTION Isotretinoin, USP a retinoid, is available as Claravis ™ (isotretinoin capsules USP), in 10 mg, 20 mg, 30 mg and 40 mg hard gelatin capsules for oral administration. Chemically, isotretinoin is 13- cis -retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44.

Isotretinoin has high lipophilicity. The structural formula is: Each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium, gelatin, hydrogenated vegetable oil, polysorbate 80, soybean oil, titanium dioxide, white wax (beeswax), and vitamin E. In addition, the 10 mg capsule contains black iron oxide and FD&C yellow no.

6. The 20 mg capsule contains black iron oxide, red iron oxide and yellow iron oxide. The 30 mg capsule contains red iron oxide and yellow iron oxide.

The 40 mg capsule contains FD&C yellow no. 6. The edible imprinting ink contains: 10 mg strength, D&C red no.

7 calcium lake, FD&C yellow no. 6 aluminum lake, propylene glycol, shellac glaze, and titanium dioxide; 20 mg strength, ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide; 30 mg strength, D&C yellow no. 10 aluminum lake, FD&C blue no.1 aluminum lake, FD&C blue no.

2 aluminum lake, FD&C red no. 40 aluminum lake, iron oxide black, propylene glycol, and shellac glaze; 40 mg strength, ammonium hydroxide, iron oxide black, propylene glycol, and shellac glaze. Meets dissolution test 2. structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Embryo-Fetal Toxicity There is an extremely high risk of life-threatening birth defects when Claravis is used in pregnancy [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )]. Instruct patients who can become pregnant that they must not be pregnant during or up to one month after Claravis treatment.

Instruct patients to not donate blood during Claravis treatment and for 1 month following discontinuation to avoid blood donation to a pregnant patient. iPLEDGE REMS Claravis is available only through a restricted program called the iPLEDGE REMS [see Warnings and Precautions ( 5.2 )]. Inform patients who can get pregnant of the following notable requirements. These patients must: Enroll in the REMS Comply with REMS requirements, including: Comply with the pregnancy testing and pregnancy prevention requirements [see Use in Specific Populations ( 8.3 )] Demonstrate comprehension of the risk and REMS requirements prior to each prescription Obtain the prescription within the 7-day prescription window (i.e., within 7 days of the pregnancy test collection) Inform their health care provider if they become pregnant and stop treatment.

Inform patients who cannot get pregnant of the following notable requirements. These patients must enroll in the REMS and comply with the REMS requirements. Claravis is available only from certified pharmacies participating in the REMS.

Therefore, provide patients with the telephone number and website for information on how to obtain Claravis [see Warnings and Precautions ( 5.2 )] . Lactation Because of the potential for serious adverse reactions in nursing infants from isotretinoin, advise patients that breastfeeding is not recommended during treatment with Claravis, and for at least 8 days after the last dose of Claravis [see Use in Specific Populations ( 8.2 )]. Psychiatric Disorders Instruct patients and/or their caregivers/families that Claravis may cause depression, psychosis, suicidal ideation, suicide attempts, and aggressive or violent behavior.

Instruct patients to stop Claravis and to contact a health care provider if they develop any of these signs or symptoms [see Warnings and Precautions ( 5.3 )]. Important Administration Instructions To decrease the risk of esophageal irritation, instruct patients to swallow the capsules with a full glass of liquid. Instruct patients to administer this Claravis product with food [see Dosage and Administration ( 2.1 )].

Intracranial Hypertension (Pseudotumor Cerebri) Advise patients that intracranial hypertension (pseudotumor cerebri) has occurred with Claravis use including concomitant use with tetracyclines. Thus, advise patients to avoid concomitant use with tetracyclines and to discontinue Claravis immediately if they have symptoms of intracranial hypertension [see Warnings and Precautions ( 5.4 )]. Serious Skin Reactions Advise patients that severe skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported in patients treated with isotretinoin and to discontinue Claravis if clinically significant skin reactions occur [see Warnings and Precautions ( 5.5 )].

Inflammatory Bowel Disease Advise patients that inflammatory bowel disease (including regional ileitis) have occurred with isotretinoin use including those without a prior history of IBD and if they experience IBD symptoms, to discontinue Claravis immediately [see Warnings and Precautions ( 5.10 )]. Musculoskeletal Abnormalities Inform patients that : There have been reports of osteoporosis and fractures and that isotretinoin may have a negative effect on bone mineral density [see Warnings and Precautions ( 5.11 )].

Isotretinoin use has been associated with musculoskeletal abnormalities (e.g., arthralgia, back pain) [see Warnings and Precautions ( 5.11 )]. Inform pediatric patients and their families that isotretinoin use in pediatri…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Claravis ™ [ klar- uh -vis] (isotretinoin capsules USP), for oral use Read the Medication Guide that comes with Claravis before you start taking it and each time you get a prescription. There may be new information. This information does not take the place of talking with your health care provider about your medical condition or your treatment.

What is the most important information I should know about Claravis? Claravis can harm your unborn baby, including birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. Patients who are pregnant or who plan to become pregnant must not take Claravis.

Because of the risk of birth defects , Claravis is only available through a special program called the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS). Your healthcare provider must be enrolled in the iPLEDGE REMS for you to be prescribed Claravis. Before you start treatment with Claravis, you must enroll in the iPLEDGE REMS.

You must understand and agree to do everything required in the iPLEDGE REMS. Patients must not get pregnant: for 1 month before starting Claravis during treatment with Claravis for 1 month after stopping Claravis If you get pregnant during treatment with Claravis, stop taking it right away and tell your health care provider. Health care providers and patients should report all cases of pregnancy that happen during treatment or 1 month after stopping treatment to: FDA MedWatch at 1-800-FDA-1088, and the iPLEDGE Pregnancy Registry at 1-866-495-0654 or www.ipledgeprogram.com If you have any questions about the iPLEDGE REMS, ask your healthcare provider, or go to www.ipledgeprogram.com or call 1-866-495-0654.

Serious mental health problems , including: depression psychosis (seeing or hearing things that are not real) suicide. Some patients taking Claravis have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives.

Some people have ended their own lives. Stop taking Claravis and tell your health care provider right away if you or a family member notices that you get any of the following signs and symptoms of depression or psychosis: start to feel sad or have crying spells lose interest in activities you once enjoyed sleep too much or have trouble sleeping become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence) have a change in your appetite or body weight suicide attempts have trouble concentrating withdraw from your friends or family feel like you have no energy have feelings of worthlessness or guilt start having thoughts about hurting yourself or taking your own life (suicidal thoughts) start acting on dangerous impulses start seeing or hearing things that are not real Your health care provider may tell you to see a mental health care professional if you have any of these symptoms.

See “ What are the possible side effects of Claravis?” for more information about side effects. What is Claravis? Claravis is a prescription medicine used in patients 12 years of age and older, who are not pregnant, for the treatment of severe acne (nodular acne) that cannot be cleared up by any other acne treatments, including antibiotics.

Claravis can cause serious side effects (see “What is the most important information I should know about Claravis?” ). Claravis can only be: prescribed by health care providers that are enrolled in the iPLEDGE REMS dispensed by a pharmacy that is enrolled in the iPLEDGE REMS given to patients who are enrolled in the iPLEDGE REMS and agree to do everything required in the program. It is not known if Claravis is safe and effective in children less than 12 years of age.

Do not take Claravis if you: are pregnant, plan to become pregnant, or become pregnant during Claravis treatment. Claravis can cause life-threatening birth defects. See “What is the most important information I should…

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

aggression: Hostile or violent feelings or behavior directed toward other people.

agranulocytosis: A severe drop in a certain type of infection-fighting white blood cell, greatly raising the risk of serious infections.

alkaline phosphatase: An enzyme measured in a blood test; higher levels can point to problems with the liver, bile ducts, or bones.

ALT: A liver enzyme (alanine aminotransferase) checked by a blood test; raised levels can signal that the liver is irritated or damaged.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

arthralgia: Joint pain.

AST: A liver enzyme (aspartate aminotransferase) measured in a blood test; higher levels may point to liver or sometimes muscle injury.

ataxia: Loss of muscle coordination that makes walking, balance, and controlled movements clumsy or unsteady.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

bilirubin: A yellow substance the liver normally clears from the blood; high levels can turn the skin or the whites of the eyes yellow.

BMD: A measurement of the amount of mineral, such as calcium, in your bones, used to estimate how strong they are.

bone mineral density: A measurement of the amount of mineral, such as calcium, in your bones, used to estimate how strong they are.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

colitis: Swelling and irritation of the inner lining of the large intestine, or colon.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

contraception: Methods used to prevent pregnancy, such as birth control pills, condoms, or an intrauterine device.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

depression: A lasting low mood with loss of interest that affects everyday life.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

edema: Swelling caused by extra fluid trapped in the body's tissues.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

embryo-fetal toxicity: Harm to a developing baby in the womb, such as birth defects, slowed growth, or loss of the pregnancy.

erectile dysfunction: Trouble getting or keeping an erection.

esophagitis: Swelling and irritation of the lining of the food pipe, or esophagus.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hematuria: Blood in the urine.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

hepatotoxicity: Damage to the liver caused by a medicine or other substance.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypertriglyceridemia: A higher-than-normal level of triglycerides, a type of fat, in the blood.

hyperuricemia: A higher-than-normal level of uric acid in the blood, which can lead to gout.

in utero: Inside the womb, describing a baby before it is born.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

lactation: The making and release of milk from a mother's breasts after giving birth.

lethargy: A state of tiredness and sluggishness, often with slowed thinking or movement.

liver function tests: Blood tests that check how well the liver is working and whether it is irritated or damaged.

lymphadenopathy: Swollen or enlarged lymph nodes, often felt as lumps in the neck, armpits, or groin.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

myalgia: Muscle pain or aching.

nasopharyngitis: Inflammation of the nose and throat, commonly known as the common cold.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neutropenia: A low level of neutrophils, a type of white blood cell that fights infection, which can make it easier to catch infections.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

osteoporosis: A condition where bones become thin and weak, making them more likely to break.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

pancreatitis: Painful swelling of the pancreas, an organ behind the stomach that helps digest food and control blood sugar.

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

Pregnancy Exposure Registry: A study that collects health information from women who took a medicine while pregnant to learn how safe it is.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

proteinuria: Protein leaking into the urine, which can be a sign that the kidneys' filters are damaged.

psychosis: A state of losing touch with reality, such as seeing or hearing things that are not there or holding false beliefs.

REMS: A special FDA-required safety program that manages a serious risk, sometimes adding extra steps for patients, pharmacists, or prescribers.

reproductive potential: The ability to have children, meaning a person who could become pregnant or could father a child.

rhabdomyolysis: A serious condition where damaged muscle breaks down and releases material into the blood that can harm the kidneys.

spontaneous abortion: The natural loss of a pregnancy in its early stages, also called a miscarriage.

statistically significant: A result unlikely to be due to chance alone, suggesting a real difference between the groups being compared.

steady state: The point where the amount of medicine going in equals the amount leaving, so blood levels stay fairly even.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

suicidal ideation: Thoughts about wanting to end your own life, which can range from a passing wish to a detailed plan.

suspension: A liquid holding fine drug particles that are mixed in but not fully dissolved, so it must be shaken before use.

syncope: The medical term for fainting, a brief loss of consciousness from a temporary drop in blood flow to the brain.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

ulceration: The forming of an open sore on the skin or on a lining inside the body, such as the stomach.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 00555-0974-02 · Teva 00555-1055-56 · Teva →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

Claravis Isotretinoin 10 mg Capsule, Liquid Filled

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